Vowst (fecal microbiota spores, live-brpk)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For oral administration only.

Prior to taking the first dose, complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment with fecal microbiota spores, live-brpk.

Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of fecal microbiota spores, live-brpk. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).

Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.

The dosage of fecal microbiota spores, live-brpk is 4 capsules taken orally once daily for 3 consecutive days.

Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Fecal Microbiota Spores/Antibiotics

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Most common adverse reactions (reported in >=5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%) and diarrhea (10.0%).

There are no severe adverse reactions for this drug.

More Frequent

• Abdominal distension
• Chills
• Constipation
• Diarrhea
• Fatigue

Less Frequent

• Flatulence
• Nausea

No enhanced messaging available.

The safety and effectiveness of fecal microbiota spores, live-brpk in individuals younger than 18 years of age have not been established.

All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no data on use of fecal microbiota spores, live-brpk in pregnant individuals. Developmental toxicity studies in animals have not been conducted with fecal microbiota spores, live-brpk.

It is not known whether fecal microbiota spores, live-brpk is excreted in human milk. Data are not available to assess the effects of fecal microbiota spores, live-brpk on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for fecal microbiota spores, live-brpk and any other potential adverse effects on the breastfed child from fecal microbiota spores, live-brpk or from the underlying maternal condition.

Of the 349 adults who received fecal microbiota spores, live-brpk, 52.4% were >=65 years of age (n=183), and 28.1% were >=75 years of age (n=98). Data from clinical studies of fecal microbiota spores, live-brpk are not sufficient to determine if adults >=65 years of age respond differently than younger adults.